On September 15, 2020 Idera Pharmaceuticals, Inc. ("Idera") (Nasdaq: IDRA) reported that final data from the ILLUMINATE-204 trial investigating intratumoral tilsotolimod, Idera’s investigational Toll-like receptor 9 (TLR9) agonist, will be presented in a Mini Oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, to be held September 19-21, 2020 (Press release, Idera Pharmaceuticals, SEP 15, 2020, View Source [SID1234565174]). In addition, final results from ILLUMINATE-101 will be shared in a poster presentation.
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ILLUMINATE-204 is a multi-center, two-arm phase 1/2 trial in patients with anti-PD-1 refractory advanced melanoma. The phase 1 portion of the trial tested the safety and efficacy of increasing doses of tilsotolimod in combination with either Yervoy* (ipilimumab) or Keytruda† (pembrolizumab). The phase 2 expansion of the trial enrolled additional patients at the recommended phase 2 dose (RP2D) of 8 mg of tilsotolimod in combination with Yervoy, which is the treatment regimen being evaluated for the same indication in the Company’s registrational trial, ILLUMINATE-301. Adi Diab, M.D., of The University of Texas MD Anderson Cancer Center, will be delivering the Mini-Oral presentation as part of the Mini Oral Session on Melanoma and Other Skin Tumors.
ILLUMINATE-101 is a phase 1b trial evaluating intratumoral tilsotolimod monotherapy in patients with refractory solid tumors, which was completed in December 2019. Final results for ILLUMINATE-101 will be presented by Hani M. Babiker, M.D., of the University of Arizona Cancer Center.
In addition to presentations on these Idera-sponsored trials, AbbVie will be presenting a trial-in-progress poster on their phase 1b study to determine the safety, tolerability, pharmacokinetics, and preliminary efficacy of combinations of ABBV-368 plus tilsotolimod in subjects with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This trial is being conducted as part of an immuno-oncology clinical research collaboration between Idera and AbbVie.
The presentation titles are as follows:
1083MO: Final Results from ILLUMINATE-204, a Phase 1/2 Trial of Intratumoral Tilsotolimod in Combination with Ipilimumab in PD-1 Inhibitor Refractory Advanced Melanoma
1031P: Tilsotolimod Engages the TLR9 Pathway to Promote Antigen Presentation and Type I IFN Signaling in Solid Tumors
975TiP: Phase 1b Trial of ABBV-368 + Tilsotolimod in Combination With Nab-Paclitaxel and/or Budigalimab (ABBV-181) in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
The on-demand poster and oral presentations will be available beginning on Thursday, September 17 and Friday, September 18, respectively.
"We are very pleased that Dr. Diab will present final data from our phase 2 trial exploring tilsotolimod plus ipilimumab in advanced melanoma patients," stated Elizabeth Tarka, M.D., Idera’s Chief Medical Officer. "We are looking forward to completing our registrational trial for this indication, ILLUMINATE-301, where a comparator arm is included, and moving this potential therapy one step closer to those patients in need."
Idera also announced that the company will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 1:30 pm EDT. A live audio webcast of Idera’s presentation will be accessible in the Investor Relations section of Idera’s website at www.iderapharma.com.
About Tilsotolimod (IMO-2125)
Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate and adaptive immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.
Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint and costimulation therapies. For more information on tilsotolimod trials, please visit ClinicalTrials.gov.